The present invention relates to an apparatus for treating and/or viewing the interior of a body cavity with an energy emitting device, to an apparatus for manipulating the movement of said energy emitting device and to a system and method including same.
A number of applications are known in the art in which a light emitting device is introduced into a body cavity for treatment and/or viewing of the body cavity. One example is the uterus where excessive and/or prolonged menstrual bleeding (or chronic menorrhagia) is traditionally treated by birth control pills, other hormonal therapies, or by a minor operation called xe2x80x9cD and Cxe2x80x9d (dilation and curettage) involving a scraping of the lining of the uterus. When such treatments are not effective, a hysterectomy is generally performed which involves removing the uterus and the lining along with it. Approximately 600,000 hysterectomies are performed in the USA each year.
An alternative method of tissue destruction is known as interstitial thermo-therapy (ITT). In this method, the tissue temperature is elevated above a certain threshold temperature for a certain duration by absorption of light. Light, in turn, is transmitted to the scene via an optical fiber and is scattered and diffused to be absorbed by the volume of tissue to be destroyed. Usually, the light source is a laser, such as a Nd:YAG laser system or Diode laser system.
Recently, a technique has been developed using laser energy to ablate the uterine lining such as to cause scarring that prevents the lining from growing back. In this technique, a laser beam is conducted into the uterus by means of an optical fiber. The optical fiber is inserted via a channel of a hysteroscope, enabling the physician to view the interior of the uterus as the physician manipulates the tip of the optical fiber. The physician sweeps the tip of the optical fiber across the uterine lining to ablate the lining to a depth of about 3-5 mm. This procedure is carried out under general anesthesia by a skilled operator, is time consuming and there is a risk of uterine perforation.
An alternative technique is to slowly and simultaneously elevate the temperature of the whole surface being treated. This is carried out by scattering light from the optical fibers. The fibers used for transmitting and diffusing the laser light are generally known as induced interstitial thermotherapy (ITT) fibers.
ITT fibers are well known. An example of an optical device which uses ITT fibers is described in U.S. Pat. No. 5,449,354, incorporated herein by reference, which discloses a device for treating the interior of a body cavity with laser energy particularly useful for the procedure. The described apparatus comprises at least two optical fibers each having a distal end adapted to be inserted into the body cavity to be treated, and a proximal end to be located externally of the body cavity and to be coupled to a source of laser energy. One of the optical fibers is axially movable with respect to the other optical fiber to either a retracted, non-operative position or to an extended, operative position. The distal ends of the two optical fibers are mechanically coupled together such that movement of one optical fiber axially with respect to the other causes the distal ends of the two optical fibers to spread apart laterally, and to direct the laser energy outwardly of the optical fibers.
In the preferred embodiment described in that patent application, the optical fibers are disposed within a cannula having a distal end adapted to be inserted into the body cavity to be treated, and a proximal end to be located externally of the body cavity when the distal end is inserted therein. In the described device, there were three optical fibers within the cannula arranged in side-by-side relation, with two of the fibers being outer fibers, and the third fiber being the middle fiber straddled on opposite sides by the two outer fibers. The two outer fibers are axially movable with respect to the middle fiber, and the distal ends of the three fibers are mechanically coupled together such that movement of the two outer fibers axially with respect to the middle fiber causes the distal ends of all three fibers to spread apart laterally.
As described in U.S. Pat. No. 5,449,354, such a laser device is particularly useful for treating chronic menorrhagia since a single dosage of laser energy will substantially cover most or all of the uterine lining. Thus, the device avoids the need for the physician to view the interior of the uterus, and thereby the need for inserting a hysteroscope into the uterus. In addition, it reduces the dilation required of the uterus, and also substantially reduces the time of treatment. Local anesthesia can be used and the procedure can be carried out with minimal training at lower risk to the patient.
U.S. Pat. No. 5,733,279 incorporated herein by reference, discloses a further device for treating the interior of a body cavity with laser energy without the need for a cannula, thereby reducing the dilation required of the uterus during treatment. The apparatus describes a device having at least two outer fibers and a middle fiber, in side-by-side relation each having a distal end to be inserted into the body cavity to be treated, and a proximal end to be located externally of the body cavity and to be coupled to a source of laser energy, and actuator means coupled to the optical fibers. In the preferred embodiment described in that patent application, the actuator means comprises rods for coupling each of the outer fibers to the middle fiber, one end of the rods is pivotally connected to each of the distal ends of the outer fibers and the other end is pivotally connected to the middle fiber. This arrangement allows for manually activating the proximal end of the outer fibers to move axially with respect to the middle fiber so that the distal ends of the fibers spread.
The above referred to devices use three optical fibers which can be manipulated to spread out within the interior of the body cavity being treated. Access to a body cavity, such as the uterus, for example, is via a relatively narrow opening, through which the devices must be manipulated. The width of devices which are composed of several fibers may be greater than the opening, thereby possible causing discomfort to the patient when being inserted. Since it is desired that treatment be carried out as a local or office procedure without general anesthesia, it is preferable that the device be as narrow as possible.
The present invention provides a system and method including a device utilizing a single optical fiber which can be manipulated within the body cavity so as to comprehensively treat the body cavity. A feature of the present invention is a device which can be controlled both longitudinally and laterally.
A further feature of the present invention is a second optic fiber for visualizing the cavity being treated which can be used in combination with the treatment fiber.
There is thus provided, in accordance with a preferred embodiment of the present invention, a device for manipulating movement within a body cavity which includes an optical fiber coupled to an energy source and a sleeve for containing the fiber. The fiber has distal end for positioning adjacent to the surface being treated and a proximal end located external to the body cavity which is coupled to an operating device for controlling the lateral and/or longitudinal movement of the fiber.
The optical fiber used for treatment may be a single induced interstitial thermotherapy (ITT) fiber.
Furthermore, in accordance with a preferred embodiment of the present invention, the lateral movement includes a plurality of stepped movements wherein after each step the operating device is activatable for a pre-determined period of time.
Furthermore, in accordance with a preferred embodiment of the present invention, the optical fiber has a variable cross-section for emitting a variable intensity of light or a uniform cross-section emitting a constant intensity of light. The optical fiber may be enclosed within a disposable sterile cover.
Furthermore, in accordance with a preferred embodiment of the present invention, a second optical fiber is included having a distal end for positioning adjacent to the surface being treated and a proximal end located external to the body cavity which is coupled to a light energy source. The second optical fiber is linked with the first optical fiber and the movement of the first and second optical fibers is synchronized.
In addition, in accordance with a preferred embodiment of the present invention, the lateral and/or longitudinal movement is either fixed, manually operated or operated by a motor coupled to the sleeve.
Furthermore, in accordance with a preferred embodiment of the present invention, the operating device includes a handpiece adapted to hold the proximal end of the optical fiber for controlling the lateral and/or longitudinal movement of the sleeve.
Additionally, there is provided, in accordance with a preferred embodiment of the present invention, a system for treating a body cavity. The system includes a light emitting source, an optical fiber for directing light from the light emitting source within the body cavity and an operating device connected to the sleeve for controlling at least the lateral movement of the sleeve thereby to correspondingly control the movement of the fiber.
The light emitting source is a laser or an incoherent light source.
In addition, there is also provided, in accordance with a preferred embodiment of the present invention a method for manipulating an optical fiber within a body cavity. The optical fiber has a distal end for positioning within the body cavity and a proximal end located external to the body cavity which is coupled to a energy source. The method includes the steps of:
inserting the optical fiber within a sleeve;
connecting the sleeve to an operating device; and
controlling the movement of the operating device thereby to control the movement of the sleeve and to corresponding control the movement of the distal end of the optical fiber within the body cavity. The movement is either lateral and/or longitudinal.
The step of controlling the movement includes the step of manually adjusting the operating device or coupling a motor to the sleeve and controlling the movement by adapting the motor to perform a pre-determined movement pattern.